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Clinical Trials/NCT01662570
NCT01662570
Completed
Not Applicable

Beverage Choice and Lifestyle Modification in Overweight Youth

University of Pennsylvania1 site in 1 country65 target enrollmentMarch 2008
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Pennsylvania
Enrollment
65
Locations
1
Primary Endpoint
Body Mass Index Percentile (BMI%)
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. This research study developed and tested a "Beverage Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are at-risk for being overweight or are overweight and who consume large amounts of sugar sweetened beverages and juice. The overall study objectives were to test the acceptability and effectiveness of the BCLM intervention for improving the weight status, energy (kcal) intake, beverage selections and beverage preferences of children in targeted age and BMI group. The investigators hypothesized that those children randomized to the BCLM group will show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and energy intake than those assigned to our Nutrition Education (NE) group.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
January 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ages 4-8 years old
  • BMI≥85th percentile (based on age and sex)
  • consumes large (≥16 oz.day) sugar sweetened beverages

Exclusion Criteria

  • Child has a serious medical condition
  • Signs of elevated psychopathology are present, as assessed by the Child Behavior Checklist (CBCL)
  • Parent demonstrates elevated psychiatric problems or eating disorders
  • Failure of parent or child to meet BMI criteria

Outcomes

Primary Outcomes

Body Mass Index Percentile (BMI%)

Time Frame: Baseline and Month 6

Change in BMI% will be measured from baseline to end of treatment (month 6).

Body Mass Index (BMI)

Time Frame: Baseline and Month 6

Change in BMI will be measured from baseline to end of treatment (month 6).

Body Mass Index z-score (BMI-z)

Time Frame: Baseline and month 6

Change in BMI-z will be measured from baseline to end of treatment (month 6).

Child percent overweight

Time Frame: Baseline and Month 6

Change in child percent overweight will be measured from baseline to end of treatment (month 6).

Waist Circumference

Time Frame: Baseline to Month 6

Change in waist circumference will be measured from baseline to end of treatment (month 6).

Energy (kcal) intake

Time Frame: Baseline to Month 6

Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.

Sugar-sweetened beverage intake

Time Frame: Baseline to Month 6

Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).

Treatment acceptance and satisfaction

Time Frame: Month 6

Overall treatment acceptance and satisfaction will be measured at end of treatment.

Secondary Outcomes

  • Child preferences and motivation for sugar-sweetened beverages(Baseline and Month 6)

Study Sites (1)

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